Italy has opened its 2025 direct-purchase pharmaceutical payback process while a central element of the mechanism is under review by the Constitutional Court. The two developments place current company liabilities alongside growing uncertainty over the future structure of one of Italy’s main medicine-spending controls.
The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) reported on 30 July that direct-purchase expenditure exceeded the 8.30% statutory ceiling by €4.767 billion in 2025. Its Board calculated the resulting aggregate company payback at €2.385 billion and approved company-specific market shares for the next stage of the procedure.
Companies can examine their data through AIFA’s Spending-Pha system and submit observations, counterarguments or supporting documents by 14 September. AIFA will then issue the determination allocating final company liabilities across regions and autonomous provinces. Payment will be due within 30 days of that determination.
The process continues despite a 2 July order from the Lazio Regional Administrative Court (Tribunale amministrativo regionale per il Lazio, TAR Lazio). TAR Lazio referred to the Constitutional Court (Corte costituzionale) whether legislation continuously requiring companies to finance 50% of the relevant direct-purchase overshoot is compatible with Articles 3, 23, 41 and 117 of the Constitution.
The court questioned whether a mechanism previously justified partly as a solidarity contribution has become a systematic and recurring source of healthcare financing, with an annual burden that companies cannot predict precisely. Legal commentary notes that this departs from recent administrative judgments rejecting similar challenges.
The referral also coincides with the Government Delegation Bill on Pharmaceutical Reform (Delega al Governo per la riforma e il riordino della legislazione farmaceutica, A.S. 1786), whose Senate committee examination ended on 14 July. The bill separately provides a legislative route for revising expenditure ceilings and payback. Companies therefore remain liable under the existing system while both constitutional review and pharmaceutical reform could reshape its longer-term operation.
Source: Italian Medicines Agency, AIFA
Link: Ripiano della spesa farmaceutica per acquisti diretti per l’anno 2025 - Avvio del procedimento - Pubblicazione dei dati (Payback of pharmaceutical expenditure for direct purchases for 2025 – start of procedure – publication of data)
Date: 30 July 2026
Source: Administrative Justice
Link: News UM n. 77/2026. Alla Corte costituzionale il meccanismo di ripianamento del payback farmaceutico (News UM no. 77/2026. Pharmaceutical payback mechanism referred to the Constitutional Court)
Date: 2 July 2026
Source: Senate of the Republic
Link: Resoconto sommario n. 428 del 14/07/2026 (Summary record no. 428 of 14 July 2026)
Date: 14 July 2026
